Wednesday, May 27, 2015

CALIFORNIA MOVING TO CHANGE ITS CHEMICAL WARNING LABELS BY END OF 2015




The California Safe Drinking Water & Toxic Enforcement Act of 1986, as Prop 65 is more formally known, requires businesses to give people “clear and reasonable warning” before they expose them to any chemical known to the state to cause cancer or reproductive toxicity. 

About 850 chemicals, including ingredients in pesticides, household products, foods, drugs, dyes, and solvents, are subject to the law. 

The overwarning problem arose because manufacturers often slap Prop 65 warning labels on their products as a way to avoid lawsuits. 

Indeed, some plaintiffs’ lawyers troll for products or places in California that lack Prop 65 warning labels and then file suit for alleged noncompliance. 

In other words, manufacturers and business owners are getting sued and the plaintiffs’ lawyers are getting rich, Gorsen says. Given this situation, nearly everyone agrees that Prop 65 is in need of an overhaul to reduce lawsuits and overwarning. But there is little agreement on how, exactly, to fix the law. 

The chemical industry, environmental groups, and state officials all have varying, sometimes contradictory ideas about what to do. California’s Office of Environmental Health Hazard Assessment (OEHHA) earlier this year released a proposal for sweeping changes to Prop 65 warning labels. 

The agency says it is on track to finalize the modifications by the end of 2015. The proposed changes, the agency says, would reduce litigation and consumer confusion. 

Chemical manufacturers and some consumer advocates say just the opposite would happen. They and many other groups are urging the agency to withdraw the proposed rule or make significant revisions.


The California agency that implements Proposition 65 – perhaps the nation’s highest-profile consumer product toxics law – has proposed far-reaching changes to the now-familiar warnings required under that statute. 
California EPA’s Office of Environmental Health Hazard Assessment (OEHHA) would radically revamp Proposition 65 (The Safe Drinking Water and Toxic Enforcement Act of 1986) to require warnings that specifically identify key toxic chemicals, hyperlink to OEHHA information and use more forceful language that differs for food versus other consumer products. 
All food and consumer product businesses doing business in California are well advised to track the progress of these proposals and plan carefully for their implementation. 
Proposition 65 requires businesses to provide warnings when their products “expose” Californians to a long list of chemicals the state has determined cause cancer or reproductive harm.  These warnings have become a ubiquitous sight in California (e.g., “WARNING: This product contains a chemical known to the State of California to cause cancer and reproductive harm”).  If adopted, OEHHA’s regulatory changes would dramatically alter these warnings for the first time in decades.
With US$785,000 in additional funding directed by the governor’s office, OEHHA has proposed to require warnings to:
1.      Specifically disclose 12 common Proposition 65-listed chemicals that require warnings, such as lead and mercury, in the text of the warning
2.      Provide a link to a new OEHHA website to allow the public to access more information relating to each product warning, including additional chemicals, routes of exposure and, if applicable, any actions that individuals could take to reduce or avoid the exposure and
3.      Differentiate consumer products and foods
12 KEY CHEMICALS TO BE IDENTIFIED IN WARNINGS
Long requested by consumer advocate organizations, OEHHA’s proposed regulations would require warnings to specifically identify exposures to at least 12 key chemicals (or combinations) “commonly found in consumer products, including foods”:
acrylamide 
arsenic
benzene
cadmium
chlorinated tris
1,4-dioxane
formaldehyde
lead
mercury
phthalates
tobacco smoke and
toluene


The process OEHHA used to develop this initial list is not clear.  But OEHHA states the list is not static or exhaustive and is likely to grow
As the final proposed regulations were developed, consumer product businesses contested specifying these 12 chemicals on warnings for two reasons.  First, businesses fear consumers would not understand the relative risks, uses or properties of these listed chemicals, making informed consumer responses difficult.  For instance, while consumers might understand and respond easily to warnings regarding lead or tobacco smoke, warnings about chlorinated tris or 1,4-dioxane might draw less-informed responses.  Second, warnings will become lengthier and potentially quite cumbersome, particularly if a product contains three or four listed chemicals.  OEHHA, however, discounts this risk and does not anticipate that warnings will contain more than one or two chemicals on the list.
OEHHA WEBSITE AND OBLIGATIONS
OEHHA plans to launch a revamped website to provide the public with a greater volume of consumer-friendly Proposition 65 information. 
The proposed regulations would require a business implementing a Proposition 65 warning to inform OEHHA within 30 days of:

The name and contact information for the person providing the warning and the manufacturer of any product the warning is intended to cover 

The specific products or category the warning covers, including barcodes, if any 

The type of occupational exposure the warning is intended to cover, if any 

The type of environmental exposures the warning is intended to cover, if any, and the affected area 

The chemical or chemicals for which the warning is being provided 

Whether the warning is for cancer, or reproductive harm, or both 

The anticipated pathways of exposure for which the warning is being provided 

Reasonably available information concerning the anticipated level of human exposure to the listed chemical, if known 

Information concerning actions a person can take to minimize or eliminate exposure to the listed chemical, if any and 

Whether the warning is being provided in any language other than English and a copy of the translated warning, if any.




The revamped OEHHA website would be populated using this new information.  Moreover, these major new information reporting burdens would rest entirely on individual businesses.  While businesses could coordinate some reporting information through trade groups or other organizations, the OEHHA website reporting requirements would create major new expenses for consumer product businesses selling in California.
MORE FORCEFUL WARNING LANGUAGE, AND DIFFERENCES FOR FOOD AND CONSUMER PRODUCTS
OEHHA’s proposed regulations significantly change the now-familiar warning message: “WARNING: This product contains a chemical known to the State of California to cause cancer and reproductive harm.”  The phrase “will expose you to” would replace the word “contains.”  OEHHA concludes the word “contains” does not sufficiently clarify that individuals will actually be exposed to a chemical if they use a given product.  Businesses have objected to the new phrase, believing it will cause unnecessary distress and inaccurately imply that an “exposure” will occur in every use of the given product.
For consumer goods, the proposed regulations would require the international health hazard symbol in warnings:
OEHHA asserts this symbol will make warnings more effective.
Food products would not need this or any other symbol because, OEHHA reasons, food product labeling does not generally include pictograms.  Instead, OEHHA would require food warning labels messages to add the word “consuming,” resulting in the phrase: consuming this product will expose you to…
For both consumer product and food warnings, OEHHA regulations would clarify:
  • Responsibility for compliance rests with the manufacturer, producer, distributor, or packager of the consumer product or food
  • Warnings must use one or more of the following methods, singly or in combination:
    • Warning on product’s label
    • For Internet purchases, warning before the consumer completes purchase
    • For catalog purchases, warning in a manner that associates the warning with the item being purchased
    • For store purchases, a shelf sign
    • Product-specific warning via electronic means that does not require the consumer to seek out the warning and
    • Listing any of the 12 specified chemicals that are applicable.
SOME FLEXIBILITY FOR INDUSTRY

While onerous and expensive, the proposed regulations would provide some minimal flexibility and an opportunity to prepare for compliance.  OEHHA would provide the opportunity to propose product-specific, area-specific or chemical-specific warnings that deviate from the regulatory standard, subject to OEHHA approval.  In theory, this flexibility would allow tailored warnings where the regulatory provisions are lacking.  The new regulations also would provide a grace period, recognizing court-approved settlements with warning content before January 1, 2015.